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European Medicines Agency validates Oasmia Pharmaceutical AB’s application to add efficacy data to the approved Apealea
Jan. 15, 2019 09:01AM PST
Life Science Investing NewsOasmia Pharmaceutical AB (NASDAQ:OASM) AB today announce that the European Medicines Agency (EMA) has validated a type II variation application to add efficacy data to the Apealea product information. Validation of the application confirms that the submission is complete and that the EMA assessment process begins. As quoted in the press release: Based on the …
Oasmia Pharmaceutical AB (NASDAQ:OASM) AB today announce that the European Medicines Agency (EMA) has validated a type II variation application to add efficacy data to the Apealea product information. Validation of the application confirms that the submission is complete and that the EMA assessment process begins.
As quoted in the press release:
Based on the EMAs procedural timelines, Oasmia anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of Q1 or beginning of Q2 2019.
The application is based on subpopulation data (n=599) from the OAS-07OVA study and aims to provide treating physicians with efficacy data for Apealea in combination with carboplatin for the approved indication; adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The current efficacy data describes the population in OAS-07OVA that also included patients with several disease relapses (n=789).